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This study is conducted in Europe. The aim of this study is to estimate the relationship between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous (i.v.) administration of insulin detemir and human soluble insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin detemir 60 pmol/kg/min | Experimental | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
|
| Insulin detemir 120 pmol/kg/min | Experimental | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
|
| Human insulin 6 pmol/kg/min | Active Comparator | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp |
|
| Measure | Description | Time Frame |
|---|---|---|
| Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Steady state glucose infusion rate (GIR) | 8 hours | |
| Steady state insulin interstitial concentration | 8 hours | |
| Ratio of steady state serum insulin concentration to interstitial insulin concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graz | 8036 | Austria |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| human soluble insulin | Drug | Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp |
|
| 8 hours |
| Insulin concentration profiles | 8 hours |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |